Regulatory and Legal
Fixing the 510(k) Process: Overhaul Would Be Overkill
Recent events—including media attention on what some have called inconsistent application of the process—have triggered FDA to take a look at the 510(k) process. And although a review of the process is good, care must be taken to avoid overdoing it. The process does work...
The Need for Compliance as a Business Strategy
   Numerof    Abrams    Rothenberg Viewed broadly, increasingly strict compliance requirements are part of an array of steadily growing pressures that the medical device industry faces, including rising product development...
Finding Harmony in a New Auditing Program
Ramaley stresses the need for a single credible and transparent accreditation process for medical device manufacturers worldwide. The quest to harmonize medical device regulations isn’t simple. One area that poses a potentially large threat to the global device trade...
RA/QA/QC Responsibilities
Developing SOPs. Implementing the SOPs. Monitoring. Auditing. GCP training. Filing an adverse event report. Filing premarket clearance applications. Conducting internal audits. Determining the root cause of a problem that involves compliance with FDA requirements. Overseeing the...
Will FDA Be Able to Crack the Regulatory Whip on Industry?
A year after trumpeted change arrived with the Obama administration at FDA, an ideological battle brews ahead of the midterm elections about where the agency should be headed. Should it hold the status quo or crack down on industry? Proindustry, antigovernment commentators like the...
Product Policy Aims to Meet Regulatory Rules
SABIC’s regulatory structure is designed to help OEMs manage material changes without sacrificing productivity, says Tom O’Brien. SABIC Innovative Plastics has created a comprehensive healthcare product policy with the intent of supporting OEMs in achieving...
How To Avoid Off-Label Device Promotion
Sara E. Dyson Severe legal penalties await companies that promote the use of their medical devices for procedures unapproved by FDA. Federal law prohibits such off-label promotion, but the practice occurs frequently in the medical technology and life sciences industries....
Following the Road to Regulation
Zecchini Clinical laboratory tests account for more than $30 billion in annual expenditures in the United States, according to the Center for Medicare Advocacy.1 More than 6 billion tests are conducted yearly in more than 200,000 testing sites.2 In response to some public...
2009 MedTech Snapshot
Manufacturing, business, and regulatory facts are critical for medical device firms to make decisions. The MedTech Snapshot is designed to give device makers a grasp on the current state of the industry. The following pages provide data on the trends that have the greatest...
Mapping the Regulatory Path of Digital Pathology Systems
Whole-slide images, as pictured here can indicate various pathologies. At issue is whether these images can or should replace traditional microscopy. Image courtesy of APERIO A new system has been overtaking the microscope as a tool for diagnosing pathogens. Whole-slide...